CHEST Physician

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

Interventional chest and diagnostic procedures

Impact of COVID-19 pandemic in patients with non-advanced LC

The COVID-19 pandemic has challenged the way we screen for, diagnose, and treat lung cancer.1, 2 Knowing that these patients are at higher risk of respiratory failure, and that COVID-19 causes poor outcomes in cancer patients,^1,3,4 valid concerns regarding viral transmission to patients and health-care workers have hampered the expedited care this population needs.

In recent months, efforts to manage the pandemic have been herculean. With the goal of limiting transmission, expert panels have offered guidance including limiting access to medical facilities, decreasing aerosolizing procedures, and prioritizing curative treatments.^2,5 In general, lung cancer screening should be delayed, and patients with highly suspicious localized pulmonary lesions could receive empiric regimens, surgery, or stereotactic radiotherapy.^1,3-5

The conundrum occurs when diagnostic bronchoscopy is required for staging, acquiring tissue for targeted therapy, or a moderate-risk pulmonary nodule with indeterminate PET-CT and/or high-risk for CT-guided biopsy. Thoughtful balancing of risks and benefits depends on patient comorbidities, hospital resources – such preprocedural COVID screening, adequate protective personal equipment- and rate of local viral prevalence.^6,7 Delaying diagnosis and staging could lead to progression of cancer and preclude curative or adjuvant therapy for appropriate candidates. Furthermore, we should not dismiss the appalling psychological impact of delayed care on our patients.

While the pandemic continues and challenges arise in the care of patients with lung cancer, the value of a multidisciplinary input and individualized care cannot be overstated, with focus on providing the best care possible while both minimizing transmission and increasing the chances of acceptable outcomes.

Jose De Cardenas MD, FCCP – Steering Committee Member

Abdul Hamid Alraiyes MD, FCCP – Steering Committee Member

References

1. Mazzone PJ, et al. Chest. 2020;158(1):406-415. doi: 10.1016/j.chest.2020.04.020.

2. Banna G, et al. ESMO Open. 2020;5(2):e000765. doi: 10.1136/esmoopen-2020-000765.

3. Liang W, et al. Lancet Oncol. 2020;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6.

4. Singh AP, et al. JCO Oncol Pract. 2020 May 26;OP2000286. doi: 10.1200/OP.20.00286.

5. Dingemans AC, et al. J Thorac Oncol. 2020;15(7):1119-1136. doi: 10.1016/j.jtho.2020.05.001.

6. Wahidi MM, et al. J Bronchology Interv Pulmonol. 2020 Mar 18. doi: 10.1097/LBR.0000000000000681.

7. Pritchett MA, et al. J Thorac Dis. 2020;12(5):1781-1798. doi: 10.21037/jtd.2020.04.32.


 

Pediatric chest medicine

FDA strengthens the boxed warning for montelukast

Early this year the Food and Drug Administration (FDA) updated the boxed warning for montelukast (Singulair), related to the potential for serious mental health side effects, such as agitation, aggressive behavior, depression, hallucinations, and suicidal thoughts and actions. Since its approval in 1998, montelukast is part of the therapeutic approach for persistent asthma in children age 1 year and older, allergic rhinitis from 6 months and older, and exercises induced bronchospasm in children age 6 years and older. In 2018, around 2.3 million children younger than 17 years received a prescription for montelukast.

The FDA reviewed data from their Sentinel System comparing children receiving montelukast vs inhaled corticosteroids, and this study failed to demonstrate significant increased risk of hospitalized depressive disorders, outpatient depressive disorders, self-harm, or suicide. However, a focused evaluation by the FDA of suicides identified 82 cases of completed suicides associated with montelukast, and 19 of these cases were in children younger than 17 years of age.

Post-marketing case reports submitted to the FDA, published observational and animal studies were evaluated along with the Sentinel System study that led to the new recommendations.

Finally, on March 4, 2020, the FDA updated the Singulair®/montelukast black box warning, focusing on the importance of advising patients and caregivers about the potential for serious neuropsychiatric side effects and advice to immediately discontinue use if symptoms occurred. The warning contains a strong recommendation to reserve use of Singulair®/montelukast to patients with allergic rhinitis who have an inadequate response or intolerance to alternate therapies.

Endy Dominguez Silveyra, MD - Fellow-in-Training Member
 

References

1. FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. FDA Drug Safety Communication, March 4, 2020.

2. Neuropsychiatric events following montelukast use: A propensity score matched analysis. Sentinel, Sept. 27, 2019.


 

Pulmonary physiology, function, and rehabilitation

The happy hypoxic

In early December 2019, the novel coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified. Over the ensuing months, SARS-CoV-2 would cause a wide range of pulmonary symptoms from cough and mild shortness of breath to acute respiratory distress syndrome (ARDS) with severe hypoxia that puzzled intensivists worldwide.

One such mystifying presentation was finding patients with critically low oxygen levels who did not appear to be short of breath. This concept was dubbed “happy or silent hypoxemia.” Novel mechanisms of the SARS-Co-V-2 virus on the respiratory system have been proposed to explain this paradox, but recent literature suggests that foundational pulmonary physiology concepts can explain most of these findings.¹

Breathing is centrally controlled by the respiratory center in the brain stem and is influenced mainly by dissolved carbon dioxide and pH.² Hypercapnia is, therefore, a powerful stimulus to breathe and increase minute ventilation. It can cause dyspnea if this demand is not met.³

Hypoxia, on the other hand, is less powerful and does not evoke dyspnea until the PaO₂ drops below 60 mm Hg.⁴ Hypercapnia potentiates this response: the higher the PaCO₂, the higher the hypoxic response. Patients with a PaCO₂ of 39 mm Hg or less may not experience dyspnea even when hypoxia is severe.¹

Other possible explanations for silent hypoxemia include the poor accuracy of the pulse oximeter for estimating oxygen saturation of less than 80%,¹ especially in the critically ill5 and the leftward shift of the oxygen dissociation curve due to fever, making the oxygen saturation lower for any given PaO₂.¹

In conclusion, the clinical management of COVID-19 pneumonia with a broad range of clinical features presents many unknowns, but it is reassuring to find an anchor in good old pulmonary physiology concepts.⁵

It is back to the basics for us all and that might be a good thing.

Oriade Adeoye, MD – Fellow-in-Training Member
 

References

1. Tobin MJ, et al. Am J Respir Crit Care Med. 2020;202(3):356-360. doi: 10.1164/rccm.202006-2157CP.

2. Vaporidi K, et al. Am J Respir Crit Care Med. 2020;201(1):20-32. doi: 10.1164/rccm.201903-0596SO.

3. Dhont S, et al. Respir Res. 2020;21(1):198. doi:10.1186/s12931-020-01462-5.

4. Weil JV, et al. J Clin Invest. 1970;49(6):1061-1072. doi:10.1172/JCI106322.

5. Tobin MJ. Am J Respir Crit Care Med. 2020;201(11):1319-1320. doi:10.1164/rccm.202004-1076ED.


 

Pulmonary vascular disease

COVID-19 and pulmonary vasculature: an intriguing relationship

Hypoxemia is the cardinal symptom in patients with severe coronavirus disease-2019 (COVID-19). However, hypoxemia disproportionate to radiographic opacities has led to growing suspicion that involvement of pulmonary vasculature (PV), leading to shunt physiology, may be a driver of this marked hypoxemia.

The virus’s affinity for PV is explained by presence of angiotensin-converting enzyme 2 receptor, which serves as the functional receptor for SARS-CoV-2, on pulmonary endothelium (Provencher, et al. Pulm Circ. 2020 Jun 10;10[3]:2045894020933088. doi: 10.1177/2045894020933088).

This increased affinity predisposes PV to pathologic effects of SARS-CoV-2, noted in COVID-19 patients’ autopsies, which revealed pulmonary endothelial injury and abnormal vessel growth (intussusceptive angiogenesis). These changes, along with profound inflammatory response, further predispose the PV to thrombosis and microangiopathy in COVID-19 (Ackermann, et al. N Engl J Med. 2020 Jul 9;383[2]:120-128).

These autopsy results also explain the radiologic findings of PV in COVID-19. Dual energy CT scanning, used to evaluate lung perfusion in these patients, has demonstrated PV thickening, mosaicism, and pulmonary vessel dilation; the latter likely occurring due to aberrations in physiologic hypoxic pulmonary vasoconstriction (Lang, et al. Lancet. 2020 Apr 30;S1473-3099[20]30367).

Despite PV’s involvement, only few cases of COVID-19 have been reported in patients with pulmonary arterial hypertension (PAH) , leading to the hypothesis that pre-existing vascular changes may have a protective effect in PAH patients (Horn, et al. Pulm Circ. 2020;10(2):1-2).

The above discussion details the complex and multifaceted relationship between COVID-19 and PV which underscores the value of understanding this interaction further and may prove to be insightful for discovering potential therapeutic targets in COVID-19.

Humna Abid Memon, MD – Fellow-in-Training Member

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

The coronavirus disease 2019 (COVID-19) pandemic has changed the way we deliver healthcare for the foreseeable future. Not only have we had to rapidly learn how to evaluate, diagnose, and treat this new disease, we have also had to shift how we screen, triage, and care for other patients for both their safety and ours. As the virus is primarily spread via respiratory droplets, aerosol-generating procedures (AGP), such as bronchoscopy and tracheostomy, are high-risk for viral transmission. We have therefore had to reassess the risk/benefit ratio of performing these procedures – what is the risk to the patient by procedure postponement vs the risk to the health-care personnel (HCP) involved by moving ahead with the procedure? And, if proceeding, how should we protect ourselves? How do we screen patients to help us stratify risk? In order to answer these questions, we generally divide patients into three categories: the asymptomatic outpatient, the symptomatic patient, and the critically ill patient.

The asymptomatic outpatient

Early in the pandemic as cases began to spike in the US, many hospitals decided to postpone all elective procedures and surgeries. Guidelines quickly emerged stratifying bronchoscopic procedures into emergent, urgent, acute, subacute, and truly elective with recommendations on the subsequent timing of those procedures (Pritchett MA, et al. J Thorac Dis. 2020 May;12[5]:1781-1798). As we have obtained further data and our infrastructure has been bolstered, many physicians have begun performing more routine procedures. Preprocedural screening, both with symptom questionnaires and nasopharyngeal swabs, has been enacted as a measure to prevent inadvertent exposure to infected patients. While there are limited data regarding the reliability of this measure, emerging data have shown good concordance between nasopharyngeal SARS-CoV-2 polymerase chain reaction (PCR) swabs and bronchoalveolar lavage (BAL) samples in low-risk patients (Oberg, et al. Personal communication, Sept 2020). Emergency procedures, such as foreign body aspiration, critical airway obstruction, and massive hemoptysis, were generally performed without delay throughout the pandemic. More recently, emphasis has been placed on prioritizing procedures for acute clinical diagnoses, such as biopsies for concerning lung nodules or masses in potentially early-stage patients, in those where staging is needed and in those where disease progression is suspected. Subacute procedures, such as inspection bronchoscopy for cough, minor hemoptysis, or airway stent surveillance, have generally been reintroduced while elective procedures, such as bronchial thermoplasty and bronchoscopic lung volume reduction, are considered elective, and their frequency and timing is determined mostly by the number of new cases of COVID-19 in the local community.

For all procedures, general modifications have been made. High-efficiency particulate air (HEPA) filters should be placed on all ventilatory circuits. When equivalent, flexible bronchoscopy is preferred over rigid bronchoscopy due to the closed circuit. Enhanced personal protective equipment (PPE) for all procedures is recommended – this typically includes a gown, gloves, hair bonnet, N-95 mask, and a face shield. Strict adherence to the Centers for Disease Control and Prevention (CDC) guidelines for postprocedure cleaning and sterilization is strongly recommended. In some cases, single-use bronchoscopes are being preferentially used, though no strong recommendations exist for this.
 

The symptomatic COVID-19 patient

In patients who have been diagnosed with SARS-CoV-2, we generally recommend postponing all procedures other than for life-threatening indications. For outpatients, we generally wait for two negative nasopharyngeal swabs prior to performing any nonemergent procedure. In inpatients, similar recommendations exist. Potential inpatient indications for bronchoscopy include diagnostic evaluation for alternate or coinfections, and therapeutic aspiration of clinically significant secretions. These should be carefully considered and performed only if deemed absolutely necessary. If bronchoscopy is needed in a patient with suspected or confirmed COVID-19, at a minimum, gown, gloves, head cover, face shield, and an N-95 mask should be worn. A powered air purifying respirator (PAPR) can be used and may provide increased protection. Proper donning and doffing techniques should be reviewed prior to any procedure. Personnel involved in the case should be limited to the minimum required. The procedure should be performed by experienced operators and limited in length. Removal and reinsertion of the bronchoscope should be minimized.

The critically ill COVID-19 patient

While the majority of patients infected with SARS-CoV-2 will have only mild symptoms, we know that a subset of patients will develop respiratory failure. Of those, a small but significant number will require prolonged mechanical ventilation during their clinical course. Thus, the consideration for tracheostomy comes into play.

Multiple issues arise when discussing tracheostomy placement in the COVID-19 world. Should it be done at all? If yes, what is the best technique and who should do it? When and where should it be done? Importantly – how do we care for patients once it is in place to facilitate recovery and, hopefully, decannulation?

Tracheostomy tubes are used in the ICU for patients who require prolonged mechanical ventilation for many reasons – patient comfort, decreased need for sedation, and to facilitate transfer out of the ICU to less acute care areas. These reasons are just as important in patients afflicted with respiratory failure from COVID-19, if not more so. As the patient volumes surge, health-care systems can quickly become overwhelmed. The ability to safely move patients out of the ICU frees up those resources for others who are more acutely ill.

The optimal technique for tracheostomy placement largely depends on the technological and human capital of each institution. Emphasis should be placed on procedural experience, efficiency, safety, and minimizing risk to HCP. While mortality rates do not differ between the surgical and percutaneous techniques, the percutaneous approach has been shown to require less procedural time (Iftikhar IH, et al. Lung. 2019[Jun];197[3]:267-275), an important infection control advantage in COVID-19 patients. Additionally, percutaneous tracheostomies are typically performed at the bedside, which offers the immediate benefit of minimizing patient transfer. This decreases exposure to multiple HCP, as well as contamination of other health-care areas. If performing a bronchoscopic-guided percutaneous tracheostomy, apnea should be maintained from insertion of the guiding catheter to tracheostomy insertion in order to minimize aerosolization. A novel technique involving placing the bronchoscope beside the endotracheal tube instead of through it has also been described (Angel L, et al. Ann Thorac Surg. 2020[Sep];110[3]:1006–1011).

Timing of tracheostomy placement in COVID-19 patients has varied widely. Initially, concern for the safety of HCP performing these procedures led to recommendations of waiting at least 21 days of intubation or until COVID-19 testing became negative. However, more recently, multiple recommendations have been made for tracheostomy placement after day 10 of intubation (McGrath, et al. Lancet Respir Med. 2020[Jul];8[7]:717-725).

Finally, once a tracheostomy tube has been placed, the care does not stop there. As patients are transitioned to rehabilitation centers or skilled nursing facilities and are assessed for weaning, downsizing, and decannulation, care should be taken to avoid virus aerosolization during key high-risk steps. Modifications such as performing spontaneous breathing trials using pressure support (a closed circuit) rather than tracheostomy mask, bypassing speaking valve trials in favor of direct tracheostomy capping, and avoiding routine tracheostomy downsizing are examples of simple steps that can be taken to facilitate patient progress while minimizing HCP risk (Divo, et al. Respir Care. 2020[Aug]5;respcare.08157).
 

What’s ahead?

As we move forward, we will continue to balance caring for patients effectively and efficiently while minimizing risk to ourselves and others. Ultimately until a vaccine exists, we will have to focus on prevention of infection and spread; therefore, the core principles of hand hygiene, mask wearing, and social distancing have never been more important. We encourage continued study, scrutiny, and collaboration in order to optimize procedural techniques as more information becomes available.
 

Dr. Oberg is with the Section of Interventional Pulmonology, David Geffen School of Medicine at UCLA; Dr. Beattie is with the Section of Interventional Pulmonology, Memorial Sloan Kettering Cancer Center, New York; and Dr. Folch is with the Section of Interventional Pulmonology, Massachusetts General Hospital, Harvard Medical School.

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

CHEST’s premier event in pulmonary, critical care, and sleep medicine is just around the corner! Join us for CHEST Annual Meeting 2020, taking place October 18-21. We know it’s hard to plan out your schedule during an ever-changing pandemic, which is why this year’s meeting is being brought to you on a virtual platform. You’ll be able to access the meeting content from any device, in any location, at any time. It’s that convenient! Plus, you can join in immersive, interactive live sessions taught by expert faculty and followed by Q&As, or listen to prerecorded content at your own pace. Don’t worry if you’re unable to attend a session — all meeting content will be available to registrants until January 2021.

This year, you can expect:

• A keynote address by Anthony Fauci, MD, covering COVID-19.

• Over 88 live sessions, including panel and case-based discussions.

• Critically relevant sessions focusing on COVID-19 and cultural diversity.

• Original investigation presentations with new, unpublished science.

• Unique networking opportunities.

• Fun and interactive CHEST Games.

Register Today

Chestmeeting.chestnet.org

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. By Dr. Lara Jehi, et al.



Airway clearance techniques in bronchiectasis: Analysis from the United States Bronchiectasis and NTM research registry. By Dr. Ashwin Basavaraj, et al.



Emotional experiences and coping strategies of family members of critically ill patients. By Dr. Emily Harlan, et al.



Coronavirus disease and smoking: How and why we implemented a tobacco treatment campaign. By Dr. Adam Lang, et al.

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

Join the CHEST Foundation at one of its many virtual events designed around the three pillars of the organization—access, empowerment, and research—during CHEST 2020. Please check CHESTMeeting.chestnet.org for more details on each event.
 

Virtual Champion’s Circle Donor Lounge

The virtual donor lounge will act as the hub of a wheel – linking the spokes of Foundation programming and events to a central location for easy accessibility. Foundation staff and Board of Trustee members will staff the donor lounge throughout the meeting.
 

Women & Pulmonary Event – Sunday, October 18 at 11:00 AM – 12:30 PM CT

Connect with key thought leaders and participants to support the advancement of women in the fields of pulmonary, critical care, sleep medicine, and in leadership. The event includes a panel discussion on How to remain in control during a pandemic: family, career and mental wellness, followed by an intimate roundtable discussion moderated by the Women & Pulmonary council. RSVPs are necessary to attend this event.
 

CHEST Foundation Donor Reception– Sunday, October 18 7:30 PM CT

Join your colleagues and CHEST leadership for a night of fun and networking. Learn to play Texas Hold’em in a complimentary, casual poker tournament and join the high stakes tournament later this month!

Wine Night with CEO Bob Musacchio – Invite Only – Sunday, October 18 7:30 CST

Join CHEST’s CEO, Bob Musacchio for an interactive, exclusive wine night. The evening will include wine chosen from Bob’s personal favorites and kick off the CHEST 2020 annual meeting as we have never done before!
 

Young Professionals Reception – Monday, October 19, 2020 at 8:00 PM CT – Invite Only

Join your colleagues for a fun evening of trivia, prizes, and celebration! Let the Foundation show some appreciation for your commitment to chest medicine and come learn more about our work!

 

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

[email protected]

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

[email protected]

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

[email protected]

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.